Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fampyra   
Auth. number : EU/1/11/699
INN : fampridine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07X - Other nervous system drugs
Chemical subgroup: N07XX - Other nervous system drugs
Chemical substance: N07XX07 - Fampridine
(See WHO ATC Index)
Indication: Indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7)
Marketing Authorisation Holder: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/07/2011 Centralised - Authorisation EMEA/H/C/2097 (2011)5390 of 20/07/2011
27/09/2011 Centralised - Variation EMEA/H/C/2097/IB/1/G
Updated with Decision(2012)1494 of 02/03/2012
02/12/2011 Centralised - Variation EMEA/H/C/2097/IA/4
Updated with Decision(2012)1494 of 02/03/2012
16/12/2011 Centralised - Notification EMEA/H/C/2097/N/3
Updated with Decision(2012)1494 of 02/03/2012
06/03/2012 Centralised - Variation (2012)1494 of 02/03/2012
25/05/2012 Centralised - Annual renewal EMEA/H/C/2097/R/6 (2012)3458 of 22/05/2012
28/09/2012 Centralised - Notification EMEA/H/C/2097/N/8
Updated with Decision(2013)4232 of 01/07/2013
30/05/2013 Centralised - Variation EMEA/H/C/2097/II/10
Updated with Decision(2014)3554 of 22/05/2014
03/07/2013 Centralised - Annual renewal EMEA/H/C/2097/R/11 (2013)4232 of 01/07/2013
27/05/2014 Centralised - Annual renewal EMEA/H/C/2097/R/14 (2014)3554 of 22/05/2014
24/07/2014 Centralised - Variation EMEA/H/C/2097/II/16
24/10/2014 Centralised - Notification EMEA/H/C/2097/N/20